Kornimate/medical-research-clean huggingface dataset:
predicting disease progression and/or recurrence in cancer

Conditions: Patient Reported Outcome Measures; Colorectal Cancer; Pancreatic Cancer; Biliary Tract Cancer; Esophageal Cancer; Metastatic Cancer; Disease Progression; Survival Analysis

Summary: this is a prospective study addressing the challenge of predicting disease progression and/or recurrence in patients diagnosed with metastatic colorectal, pancreatobiliary, or esophagogastric cancer that are receiving anti-cancer therapy.

this research study is evaluating how patient-reported outcomes (e.g. symptoms, quality of life) and biomarkers compare to standard of care clinical assessments such as imaging and tumor markers in predicting the clinical outcomes (e.g. disease progression and survival) in patient populations with colorectal, pancreatobiliary, or esophagogastric cancer that are receiving anti-cancer therapy massachusetts general hospital cancer center * patient reported outcomes will be collected through a series of self-administered questionnaires and blood draws will be used to obtain bio and tumor marker information. * information will also be collected from the participants electronic medical record. * tissue may be obtained for next-generation sequencing. * the study will conclude after participants are no longer receiving anti-cancer therapies. * it is expected that about 200 people will take part in this research study

Eligibility criteria:
* inclusion criteria: * patients must have histologically confirmed colorectal, pancreatobiliary, or esophagogastric cancer. * diagnosed with metastatic disease * age \> 18 years. * patients must be starting new line of anti-cancer therapy. * patient must be english-speaking. * exclusion criteria * unwilling or unable to participate in the study * non-metastatic disease * not starting new anti-cancer treatment * cognitive issues interfering with ability to participate. * active, unstable, untreated serious mental illness interfering with ability to participate. * patient does not speak english.

Keywords: patient reported outcome measures colorectal cancer pancreatic cancer biliary tract cancer esophageal cancer metastatic cancer disease progression survival analysis
risk clinical stratification of sickle cell disease in nigeria, assessment of efficacy/safety of hydroxyurea treatment

Conditions: Sickle Cell Disease; Sickle Cell Anemia

Summary: the vast majority of births with sickle cell disease (scd) occur in africa and 90% are thought to die before the age of five. hydroxyurea (hu) is the only drug approved by the fda for the treatment of sickle cell anemia. although hu is used to treat small numbers of patients in africa, cost, fear of toxicity, and lack of awareness and availability limit its use. the leukopenia that may be seen with hu raises the possibility of increased susceptibility to infection. risk stratification - i.e., identification of patients most likely to benefit- could focus therapy and provide confidence that the risk:benefit ratio is favorable. several clinical measures of future risk are well defined and findings on modifier genes in the us, primarily related to fetal hemoglobin (hbf), have further improved risk prediction. whether the genetic variants predict severity in africa is not known. the investigators have established a scd cohort in ibadan, nigeria. in the first phase of this research the investigators will implement clinical risk examinations and assess the relationship between clinical characteristics (including levels of hbf) and known genetic markers. as a proxy for a birth cohort, the investigators will compare the frequency of the genetic markers in adult patients (i.e., "survivors") to children. in the second phase the investigators will randomize 40 high risk adult patients to fixed low dose hu or no hu treatment in a crossover design and monitor hematologic and physiologic parameters to document hematologic effects and safety. this work will lay the basis for a large-scale trial to document safety and efficacy.


Eligibility criteria:
inclusion criteria: * age \>= 18 years * hemoglobinss (hbss) or beta-zero (b0) thalassemia genotype * hemoglobin concentration \>4.5 g/dl at steady state and time of enrollment * absolute neutrophil count \>1,500/mircoliter * platelet count \>95,000/microliter * serum creatinine \<1.2 mg/dl * alanine transaminase less than two times the upper limit of normal exclusion criteria: * hivpositive * hepatitis b and/or c positive

Keywords: sickle cell disease sickle cell anemia hydroxyurea nigeria low income country middle income country developing country
prophylactic tricuspid annuloplasty in patients with dilated tricuspid annulus

Conditions: Tricuspid (Valve) Insufficiency (Rheumatic)

Summary: patients elected to undergo mitral valve surgery (either repair or replacement) with less equal than moderate (≤+2) tricuspid regurgitation and dilated tricuspid annulus (\>21mm/m2) at preoperative echocardiography will be screened. consenting patients fulfilling all inclusion and exclusion criteria will be included in the study and assigned to elective mitral valve replacement or repair with or without concomitant tricuspid annuloplasty in a 1:1 fashion, using a blocked randomization scheme balanced within center.

the present study is designed as a prospective, multicentre, multinational, randomized, 2-arm parallel group trial. participating centres are selected based on previous experience with the surgical technique and standardised echo imaging. each center is expected to contribute 20 to 40 patients over a 12-month enrolment period. patients elected to undergo mitral valve surgery (either repair or replacement) with less equal than moderate (≤+2) tricuspid regurgitation and dilated tricuspid annulus (\>21mm/m2) at preoperative echocardiography will be screened. consenting patients fulfilling all inclusion and exclusion criteria will be included in the study and assigned to elective mitral valve replacement or repair with or without concomitant tricuspid annuloplasty in a 1:1 fashion, using a blocked randomization scheme balanced within center. after discharge patients will be assessed at 1 month (phone contact), 6 month and 1-year after surgery.

Eligibility criteria:
inclusion criteria: patients undergoing mitral valve surgery (either repair or replacement) with less/equal than moderate (≤+2) tricuspid regurgitation and dilated tricuspid annulus (\>21mm/m2 bsa) at preoperative echocardiography and fulfilling the following selection criteria: inclusion criteria: 1. written informed consent 2. degenerative mitral valve disease 3. \> 18 years old exclusion criteria: main exclusion criteria: 1. presence of structural or organic tricuspid valve disease 2. urgent operation 3. presence of pacemaker leads through the tricuspid annulus 4. acute endocarditis or other organic valve diseases 5. previous surgical procedure 6. severe tr 7. associated cardiac procedure 8. nyha class iv 9. severe copd (gold class 3,4)
a trial investigating the pharmacokinetics and pharmacodynamics of nnc0123-0000-0338 in a tablet formulation with three different coatings in healthy subjects

Conditions: Diabetes; Healthy

Summary: this trial is conducted in europe. the aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of nnc0123-0000-0338 (insulin 338) in a tablet formulation with three different coatings in healthy subjects.


Eligibility criteria:
inclusion criteria: * body mass index 18.0-28.0 kg/m\^2 (both inclusive) * subject who is considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, ecg (electrocardiogram) and clinical laboratory tests performed during the screening visit, as judged by the investigator exclusion criteria: * known or suspected hypersensitivity to trial products or related products * previous participation in this trial. participation is defined as informed consent * presence of clinically significant acute gastro-intestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to first dosing, as judged by the investigator
simulated amniotic fluid in preventing feeding intolerance and necrotizing enterocolitis vlbw neonates

Conditions: Necrotizing Enterocolitis

Summary: the human fetus swallows over 200 ml of amniotic fluid per kilogram of weight each day and such swallowing is essential for normal small bowel development.growth factors found in the amniotic fluid have been shown to promote proliferation of fetal intestinal cells. as feeding intolerance is a common problem among premature neonates, the investigators will study the role of enteral administration of simulated amniotic fluid solution in prevention of feeding intolerance and nec in premature neonates.

very low birth weight (vlbw) neonates. participants will be followed for the duration of hospital stay until discharge or death.

Eligibility criteria:
inclusion criteria: * premature infants with birth weight 1.5 kg exclusion criteria: * congenital or acquired anomaly of the gastrointestinal tract (i.e., omphalocele, tracheoesophageal fistula, intestinal perforation). * other major congenital anomalies (congenital heart disease, neural tube defect, congenital diaphragmatic hernia, trisomy, etc.).

Keywords: feeding intolerance simulated amniotic fluid necrotizing enterocolitis
how do sleeping pills affect pain in the brain?

Conditions: Primary Insomnia

Summary: if you are age 20-55 years old and have trouble falling or staying asleep, then please contact a ucsd research team to find out how a study drug affects these symptoms and how your brain works. this is a one-week experimental pain research study using a study drug compared to placebo. your participation will include questionnaires, a physical exam and functional magnetic resonance imaging (fmri) brain imaging techniques. we will test pain perception by applying brief mild to moderate heat pain to the forearm, and also have you perform simple computer tasks while we image and record brain activity using fmri.

it is well known that chronic pain syndromes are associated with alterations in sleep continuity and sleep architecture. similarly, recent evidence indicates that sleep deprivation interferes with normal pain perception producing hyperalgesic changes, and with the regular analgesic effects of certain pain drugs (reviewed in kundermann b et al., 2004). however, the role of the nonbenzodiazepine hypnotic agents in pain perception is not well understood. lunesta (eszopiclone), unlike other nonbenzodiazepine sleep medications, is approved for long-term use (no significant addictive effects of the drug are observed following the treatment of up to 6mo). its antinociceptive properties have not been examined and, if found, could potentiate the use of this drug for pain control, especially in patients with comorbid chronic pain and insomnia. the objective of this proposal is to use functional magnetic resonance imaging (fmri) with an experimental pain paradigm in a group of chronic insomnia patients. the study will consist of three sessions, the first of which will include questionnaires, and a mental and physical health evaluation including an ekg and blood draw. following the initial screening session subjects will be randomly assigned to either the study drug or placebo groups, and complete 2 additional identical study sessions using fmri. the first fmri session will be before taking the drug/placebo, and the second session will be after taking the study drug/placebo nightly for 1 week. during these fmri sessions, subjects will undergo psychophysical testing of their sensitivity to warmth and heat and will rate various temperatures for pain intensity and pain unpleasantness. subjects will also complete additional tasks including motor inhibition and face matching during scanning.

Eligibility criteria:
inclusion criteria: * age 20-55 * primary insomnia exclusion criteria: * certain medical conditions/medications * mri related

Keywords: insomnia lunesta eszopiclone pain fmri
treatment of meniere's disease with migraine medications

Conditions: Ménière

Summary: meniere's disease (md) is a chronic disease with a variety of fluctuating signs and symptoms, which include vertigo, hearing loss, tinnitus (ringing noise in the ear), aural pressure (feeling of ear fullness), and disequilibrium (lack of stability). vertigo represents one of the most common and distressing problems in md patients, and it causes various somatic and psychological disorders that interfere with the patient's quality of life. despite the large economic and emotional impact of symptoms in md patients, there is no fda-approved medication to treat this debilitating condition. as such, our objective in this study is to evaluate the therapeutic potential of novel medications in treating md that have previously shown astonishing promise in our clinical practice.

this study is 8 weeks in duration. there are two arms in the experiment: the first is nortriptyline (7.5 mg) plus topiramate (10 mg), the second is hydrochlorothiazide (25 mg) plus triamterene (37.5 mg) with placebo being added in case of a dosage increase. this is a double-blinded trial. participants will be randomized to one arm for the duration of the trial using simple randomization with a computer-generated number. both groups may receive dosage increases weekly if symptoms do not improve. symptomatic survey scores from each arm will be obtained before and after treatment and weekly. an unblinded clinical researcher will also become involved with patients' treatments as they start to report changes in symptoms in order to monitor their safety and provide advice on change in dosage if patients have questions.

Eligibility criteria:
inclusion criteria: 1. patients with active or frequent meniere's disease. 2. male or female between the ages of 25 to 85 years. 3. subject must be compliant with the medication and attend study visits. 4. must be able to read and write in the english language to provide consenting. exclusion criteria: 1. pregnancy will result in automatic exclusion from the study. a urine pregnancy test to rule out pregnancy for all women who are of childbearing potential. 2. subjects with history of surgery for meniere's disease. 3. subject with history of an adverse reaction to medication being prescribed. 4. subject suffers from a medical condition or has history that may be concerning to the investigator's clinical opinion. 5. subjects with psychosis. 6. subjects with neurological neoplasm. 7. all contraindications for the medications which prevent subjects from randomization will be considered as exclusion criteria.

Keywords: meniere's disease, medication, randomized, trial, migraine
the treatment of addictions in the course of care in oncology: an inventory of fixtures among paramedical professionals

Conditions: Paramedical Professional

Summary: nowadays, guidance is given on the implementation of innovative approaches to promote autonomy and user participation through strategies designed to strengthen the patient's empowerment. \[sns 2018-2022, ministère des solidarités et de la santé\] the 2014-2019 cancer plan calls for the systematic support of smokers during smoking cessation. this means that health workers need to be trained to help with smoking cessation, as well as the motivational attitude that reinforces the patient's smoker's self-esteem as well as his desire to off-load this addiction. \[perriot, underner, peiffer, dautzenberg, 2018\] it is recommended that these interventions be included from the beginning of the management, once the diagnosis of cancer is made. it seems legitimate then to wonder about the place of choice the motivational interview (em) could have in the course of cancer care, for the management of addictions during the treatment of cancer. we therefore wish to carry out descriptive qualitative research in the lucien neuwirth oncology institute in order to try to define the management of addictions in the oncology care course. thus, an approach in terms of social representations among paramedical professional actors involved in the care of patients treated for cancer and with an unresolved addictive disorder sounds the best way for this research.

nowadays, guidance is given on the implementation of innovative approaches to promote autonomy and user participation through strategies designed to strengthen the patient's empowerment. \[sns 2018-2022, ministère des solidarités et de la santé\] the 2014-2019 cancer plan calls for the systematic support of smokers during smoking cessation. this means that health workers need to be trained to help with smoking cessation, as well as the motivational attitude that reinforces the patient's smoker's self-esteem as well as his desire to off-load this addiction. \[perriot, underner, peiffer, dautzenberg, 2018\] it is recommended that these interventions be included from the beginning of the management, once the diagnosis of cancer is made. it seems legitimate then to wonder about the place of choice the motivational interview (em) could have in the course of cancer care, for the management of addictions during the treatment of cancer. we therefore wish to carry out descriptive qualitative research in the lucien neuwirth oncology institute in order to try to define the management of addictions in the oncology care course. thus, an approach in terms of social representations among paramedical professional actors involved in the care of patients treated for cancer and with an unresolved addictive disorder sounds the best way for this research.

Eligibility criteria:
inclusion criteria: - voluntary participation of health professionals in the lucien neuwirth cancer institute exclusion criteria: - refusal to participate

Keywords: addiction tobacco oncology care pathways motivational attitude motivational interviewing nursing
a study of ly900014 in participants with type 2 diabetes on insulin injection therapy

Conditions: Diabetes Mellitus, Type 2

Summary: the study will be conducted in participants with type 2 diabetes on insulin injection therapy to investigate how the body processes ly900014 and the effect of ly900014 on blood sugar levels. side effects and tolerability will be documented. the study will be conducted in two parts (part a and part b) to achieve its objectives. participants are expected to enroll in both parts.


Eligibility criteria:
inclusion criteria: * are male or female participants with type 2 diabetes mellitus (t2dm) on a stable multiple daily injection regimen with a short-acting as well as a long-acting insulin * have a body mass index (bmi) ranging from 18.5 to 33.0 kilogram per square meter (kg/m²), inclusive, at screening * have blood pressure, pulse rate, electrocardiogram (ecg), blood and urine laboratory test results acceptable for the study * have had no episodes of severe hypoglycemia in the past 6 months (requiring assistance in treatment by a second party) * have venous access sufficient to allow for blood sampling * have provided written consent and are willing to follow study procedures and commit to the study duration exclusion criteria: * are currently enrolled, or have participated within the last 30 days, in a clinical trial or any other type of medical research judged to be incompatible with this study * have previously completed or withdrawn from this study * have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate in the study * had blood loss of more than 500 milliliters (ml) within the last month * are treated with a continuous subcutaneous insulin infusion (insulin pump)
a study to evaluate the drug-drug interaction and safety between "br6001-1" and "br6001-2"

Conditions: Gastric or Duodenal Ulcer

Summary: the purpose of this clinical trial is to evaluate the drug-drug interaction and safety between "br6001-1" and "br6001-2" in healthy adult volunteers


Eligibility criteria:
inclusion criteria: * those who weigh 50 kg or more and have body mass index (bmi) within the range of 18.0 to 30.0kg/m² at screening visit. * those who sign written consent spontaneously to follow the study directions after listening to and understanding sufficient explanation of this clinical trial. exclusion criteria: * those who have a medical history of gastrointestinal diseases(crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (except for simple appendectomy, hernia surgery) that may affect the absorption of investigational products. * those who have hypersensitivity reaction to investigational products or their additives in addition to other painkillers, anti-inflammatory drugs, antirheumatic drugs, benzimidazole. * those who have a history of clinically significant hypersensitivity reaction. * those taking anticoagulants, atazanavir, rilpivirine and methotrexate. * those who eat an abnormal food that may affect the absorption, distribution, metabolism and excretion of investigational products or who eat food that may affect drug metabolism. * those who take any prescription drugs(including herbal medicines) that may affect characteristics of investigational product within 14 days prior to the date of first administration or who take any over-the-counter (otc) drugs or vitamins within 10 days prior to the date of first administration (however, if it don't affect subject's safety and study's result according to the judgment of the investigator, they may participate in the study.) * those who take inducer and inhibitor of drug metabolizing enzymes such as barbiturates, etc. within 1 month prior to the first administration